NCT06128928

Brief Summary

The goal of this clinical trial is to find out which approach works better in getting more of the friends and connections of Latino adults get vaccinated against COVID-19. The main questions this study aims to answer are:

  1. 1.Can teaching people to use motivational interviewing help more friends and connections of Latino adults get the COVID-19 vaccine compared to just giving information about the vaccine?
  2. 2.What are the things that make it easier or harder for Latinos and networks to get the COVID-19 vaccine?
  3. 3.How does this intervention work in practice so that it can be made available to more people in the future

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable covid19

Timeline
6mo left

Started Jul 2023

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jul 2023Dec 2026

Study Start

First participant enrolled

July 8, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

3.5 years

First QC Date

November 10, 2023

Last Update Submit

November 7, 2025

Conditions

COVID-19Vaccine

Keywords

COVID-19 vaccine uptakeLatinovaccine hesitancyNetwork referrals

Outcome Measures

Primary Outcomes (1)

  • COVID-19 vaccine status among networks

    Number of network participants who receive the COVID-19 vaccine

    Up to 18 months

Study Arms (2)

REDES: Motivational interviewing training

EXPERIMENTAL

Participants in this arm will receive training on motivational interviewing (MI) to promote vaccine acceptance and uptake with their networks. The training will be led by community health workers on how to use MI to address vaccine hesitancy using a guiding approach, open-ended questions, affirmations, reflections, and summaries.

Behavioral: REDES

Control: COVID-19 vaccine information

ACTIVE COMPARATOR

Participants in the control condition will receive a brief community health worker-led training about the safety and efficacy of the vaccine. Participants will have the opportunity to ask clarifying questions from the community health workers during the training.

Behavioral: Control

Interventions

REDESBEHAVIORAL

Training on motivational interviewing (MI) led by community health workers on how to use MI to address vaccine hesitancy using a guiding approach, open-ended questions, affirmations, reflections, and summaries.

REDES: Motivational interviewing training
ControlBEHAVIORAL

Brief CHW-led training about the safety and efficacy of the COVID-19 vaccine. Participants will have the opportunity to ask clarifying questions from the CHWs during the training.

Control: COVID-19 vaccine information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligibility criteria for index participants (eligibility for index participants is intended to select participants who are less vaccine hesitant):
  • Age 18 years or older, and
  • Self-identifies as Hispanic/Latino, and
  • Living in Maryland, and
  • Has received at least one COVID-19 vaccine/booster in the last 12 months.
  • Eligibility criteria for primary and secondary network members (peers):
  • Eligibility for peers is intended to select for participants who are more vaccine hesitant (e.g. unvaccinated, or have not received at least one COVID-19 vaccine/booster in the last 12 months)
  • years old or older, and
  • Self-identifies as Hispanic/Latino, and
  • Living in Maryland, and
  • Provide a study coupon to verify that they were referred by an index or a primary network member, and
  • Has not received at least one COVID-19 vaccine/booster in the last 12 months.

You may not qualify if:

  • Previously participated in the study
  • Lacks capacity to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

COVID-19Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Kathleen R Page, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Cui Yang, PhD

    Rutgers University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen R Page, MD

CONTACT

(410) 321-0909kpage2@jhmi.edu

Adrianna Moore, MSW

CONTACT

410-321-0909adrianna.moore@jhmi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 13, 2023

Study Start

July 8, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 12, 2025

Record last verified: 2025-11

Locations

US(1)